A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants. |
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| Condition | Healthy |
| Intervention | Drug: Canagliflozin, 100 mg Drug: Metformin XR, 500 mg Drug: CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg Drug: CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg |
| Phase | Phase 1 |
| Sponsor | Janssen Research & Development, LLC |
| Responsible Party | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier | NCT02077803 |
| First Received | February 28, 2014 |
| Last Updated | April 11, 2014 |
| Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 28, 2014 |
|---|---|
| Last Updated Date | April 11, 2014 |
| Start Date | March 2014 |
| Estimated Primary Completion Date | May 2014 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | Number of participants with adverse events as a measure of safety and tolerability [Time Frame: Up to Day 10 of the follow-up period] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components in Healthy Fed Participants |
|---|---|
| Official Title | A Single-Dose, Open-Label, Randomized, 3-Way Crossover Pivotal Study to Assess the Bioequivalence of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) (2 x 50 mg/1,000 mg) With Respect to the Individual Components of Canagliflozin (1 x 100 mg) and Metformin XR Tablet (4 x 500 mg) in Healthy Fed Subjects |
| Brief Summary | The purpose of this study is to assess the bioequivalence (similarity of the drug amount in blood among the formulations) of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 50 mg/1000 mg) with respect to the individual components of canagliflozin (1 x 100 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants. |
| Detailed Description | This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications provided to all participants but in different sequence) study of Fixed Dose Combination (FDC) tablets of canagliflozin (CANA) and metformin extended release (MET XR) in comparison with tablets of individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets). The tablets will be of the same strength (50 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 100 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components. Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each (Days -1 through 4) separated by a washout of 10 to 14 days between Day 1 of each Treatment Period, and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure on Day 4 of Treatment Period 3. The total duration of the study will be about 70 days for each participant. |
| Study Type | Interventional |
| Study Phase | Phase 1 |
| Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Healthy |
| Intervention | Drug: Canagliflozin, 100 mg Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth). Drug: Metformin XR, 500 mg Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth). Drug: CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 1, to be taken orally. Drug: CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 2, to be taken orally. |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 42 |
| Estimated Completion Date | May 2014 |
| Estimated Primary Completion Date | April 2014 |
| Eligibility Criteria | Inclusion Criteria: - Must sign an informed consent document indicating they understand the purpose of the study and procedures - Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive - Must have a body weight of not less than 50 kg - Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening - Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests) Exclusion Criteria: - History of or current clinically significant medical illness - Use of any prescription or nonprescription medication (including vitamins and herbal supplements) - History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose - Known allergy to heparin or history of heparin induced thrombocytopenia - Donated blood or blood products or had substantial loss of blood within 3 months before screening |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT02077803 |
|---|---|
| Other Study ID Numbers | CR103257 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Janssen Research & Development, LLC |
| Study Sponsor | Janssen Research & Development, LLC |
| Collaborators | Not Provided |
| Investigators | Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC |
| Verification Date | April 2014 |
Locations[ + expand ][ + ]
| United States, Arizona | Tempe, Arizona, United States Recruiting |
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